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Monthly Archives: April 2015

The CTSI’s Trainee Pilot program offers aspiring researchers the chance to compete for a 1-year grant of up to $25,000. Courtney Jones, Ph.D., received one such award in 2012, and spoke with CTSI Stories about how the subsequent research helped shape her career.

Courtney Jones, Ph.D.

Tell us a little about your research.

My dissertation centered on risk stratification of older adults with injuries. Certain hospitals, like Strong Memorial, are designated trauma centers that have specialized resources for the care of injured patients, and when we’re making a decision on where to send a patient, we want to make sure we choose the correct facility. We don’t want to send every injured patient to a designated trauma center, because then those centers may become overwhelmed. And we don’t want to send patients who are at high risk to a community hospital because they might not have the necessary resources to care for that person.

So when the ambulance arrives on the scene, it’s really about identifying where a patient should be transported. Previous research has shown that older adults are less likely to receive trauma center care than their younger counterparts, even if they have similar injuries. We really didn’t know why that was the case.

How did you come to work with the CTSI?

I was a Ph.D. student in epidemiology when I looked into the Trainee Pilot program, and it seemed really aligned with what I was doing because my research is very translational — it has the potential to really impact patient care. So the study that I proposed to the CTSI was to evaluate two hypothesized mechanisms that we thought were at play.

First, we knew there was this age based disparity in who receives trauma center care. There are national guidelines that EMS providers follow that outline things like systolic blood pressure, respiratory rate, and how the injury occurred — was it a high speed motor vehicle crash, or did they fall off a roof, for example — that determine where a patient should be transported.

The national guidelines are structured toward the most severely injured patients — the high-risk motor vehicle crashes, falls off a roof, the incidents that you might think about being on the 5:00 news. But in older adults, we know that even a simple fall can result in a pretty high risk of mortality and the need for substantial medical resources. So we’ve hypothesized that those guidelines just don’t work as well at identifying who is high risk.

We also evaluated this phenomenon where EMS providers might perceive older adults differently. There was some preliminary research done on the west coast that Identified potential reasons why older adults are more likely to be undertriaged – our goal was expand upon this previous research.

Very interesting. Can you describe your methods?

We created a quantitative survey that we administered to 600 EMS providers across the region, and we used a factorial survey method. We presented the EMS provider with a clinical scenario with different random patient characteristics. So one provider might get a vignette with a younger adult in a motor vehicle crash who had normal systolic blood pressure. And another EMS provider would have a different patient and scenario. And we’d ask: Would you take this patient to a trauma center? Then we analyzed the statistics and evaluated how they incorporated age into their decision.

The CTSI was great because it provided us the funds to do this complex, novel study in which we evaluated multiple components of decision-making, and it especially helped in recruiting the local providers to participate in the focus groups. We were able to provide food and beverages at each of the focus groups, and we provided incentives for participation, and I don’t think I would’ve had the same success — recruiting 600 EMS providers from a fairly small region — without the incentives and the support of the CTSI.

Any results you’d like to share?

What we found in the preexisting dataset is that the national guidelines don’t work as well among older adults. The sensitivity — or the ability of the national guidelines to correctly identify severely injured older adults — for individuals less than age 55 is about 80 percent, but for people over age 70, it’s only about 52 percent. And there’s a statistically significant linear decrease in sensitivity as age increases.

So that’s quite remarkable when you think about it. It has huge implications, because if the protocol they’re using in the field doesn’t work as well among older adults, then that might explain why we see that older adults are less likely to see trauma center resources.

The focus groups and factorial surveys we did with EMS providers also generated some interesting data. We failed to find a statistically significant difference in trauma center decision making between age groups, but the protocol states that age greater than 55 should be a special consideration. So if they were following the guidelines explicitly, they should’ve been more likely to transport the older patients to the trauma center. But, in fact, we failed to find such a difference.

The surveys also generated some interesting responses, such as the notion that injuries are just expected among older adults — that grandmas just fall out of bed sometimes – and as a result these injuries may not elicit the same response from providers. So that’s interesting because it speaks to what the next steps might be. Do we need to educate EMS providers? Do we need to structure the guidelines differently such that there are separate guidelines for older and younger adults?

How has your research progressed since then?

After completing the CTSI award, my primary mentor, Manish Shah, M.D. and I applied for an NIH R03 which evaluated a similar research question. We also got a CDC U01 grant that aligned perfectly with our previous research— it was an RFA for field triage decision-making for older adults taking anti-coagulants and platelet inhibitors. So in the U01 application we put a whole section of preliminary data that was essentially the findings and methodology I used in the CTSI award.

I also used the data as the basis for my future research which I outlined in NIH loan repayment award application, where they pay a portion of your student debt for you, and that was fantastic.

Overall, the CTSI was great because it was a catalyst — it was enough seed money to really show this was a worthy topic, and we got some really exciting findings which put me on a trajectory to really make this my career. We have presented the findings at numerous conferences and have manuscripts in-press and under-review.

Also, I was a Ph.D. student at the time so it was a really great opportunity for me to be a PI, if you will, before I became a faculty member. Because as a student, that’s an experience that often gets overlooked. You’re focused on your coursework and writing your dissertation, but grants management is never really part of your education. So just learning about the budgeting and the paperwork you have to fill out, that was something very complementary to my education and was a piece I wouldn’t have received otherwise.

Per a new eRecord policy, external study monitor eRecord accounts will be deactivated between visits. Notification will now need to be provided a few days before the visit so the account can be reactivated. Deactivating study monitor (ePartner) accounts in between visits complies with URMC Information Security access control policies. This information is noted on the NEW study monitor access request form available on the eRecord site under “Research,” then “External Study Monitors.” Please note that with the new form the Principal Investigator and Program Administrator will need to sign off on the request, consistent with the request process for eRecord access for URMC research staff.

To reactivate the external study monitor access, the study team’s internal contact will need to email “eRecord External Reviewer Request” at eRecordExternalReviewerRequest@URMC.Rochester.eduat least 3 days prior to the visit and include: study name (include CTO#), study monitor name(s) and dates access is needed. New request forms must be submitted for new studies and for the addition of new study monitors to existing studies. If you have any questions please contact ResearchHelp@URMC.Rochester.edu.

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CTSI KL2 scholar Vankee Lin, Ph.D., R.N., assistant professor in the School of Nursing and Department of Psychiatry, shares her research on Alzheimer’s Disease and memory in aging adults.

The KL2 Mentored Career Development program provides 2 years of support for new investigators interested in a career in clinical or translational research. The program is designed to support the career development of those who wish to pursue research careers in multidisciplinary clinical and translational science.

Every month, the CTSI Stories Blog will post excerpts from ongoing conversations with the institute’s co-directors.

Below, Karl Kieburtz talks about how the leadership is preparing for the Clinical and Translational Science Award renewals.

The new leadership structure has been in place for three months now. How are things going?

One of the great things about the change in leadership structure is it allows each of us to direct ourselves with more emphasis toward specific areas, and one of the things I’ve focused on is trying to understand what’s happening lately at NCATS. Right now, they’re very focused on the development of new methodologies and new technologies to increase the efficiency of clinical and translational research.

In research, there’s a very long window from discoveries in the lab to treatments in humans and actually influencing the health of the population. That’s often measured in decades. Can we get that down to a sub-decade measure by improving the tools we use? That’s NCATS’s big focus, and they’re demonstrating that focus by targeting their funding toward the new methodologies and technologies.

How are they targeting the funding?

The RFA for renewals for the CTSAs is coming out again soon, but they’re also having RFAs for three new structures. One is called a Recruitment Innovation Center (RIC), one is called a Trial Innovation Center (TIC), and the third is a Collaborative Innovation Network.

So the CTSA awards are the base awards, and they’re going to be reduced on the high end for institutions that had very large awards. Fortunately, we’re already among the smaller centers, so that shouldn’t affect us as much. But they’re likely going to use that reduction to pay for these new awards, and the way you grow your base award is by applying for one or more of these new structured grants.

Can you describe what they’re looking for in terms of RICs, TICs, and Collaborative Innovation Networks?

A RIC is responsible for new or more efficient ways to drive recruitment. Here, for example, through the National Center for Deaf Health Research, we’ve done a lot with the deaf community. So we’re thinking about whether that could be used as a model to recruit and engage with underserved communities, or communities with health disparities.

For the TIC, one example that would apply here is the work that Ray Dorsey has been doing with mobile technology. The mPower app, which is the Apple app that was highlighted recently, allows you to record your medications, record memory activities, there’s a voice activity, a measured gait activity. And that kind of tool is exactly the kind of methodology they’re looking for in terms of clinical trials, because it’s much more efficient than having people come into their research visits once a month.

For something like mPower, you can arrive at estimates of benefits faster. A lot of trials go on for a long period of time and are bigger because of there’s a lot variability of the data. But if you can get more data from fewer people, you can run trials faster, and you’re more efficient because there isn’t so much inter-individual variability. You often hear about certain advancements in research costing X billion dollars, but the reason for that cost is you’re actually amortizing all the failures in addition to the success. For every success, you might have 100 failures or 200 failures. But those 200 failures don’t happen early. They happen over the course of a trial or late in a trial. So one of my hopes is that by getting more accurate data early, you can fail earlier. It seems counterintuitive, but if you can cut off a line of study and save costs on something that’s ultimately going to fail, you can learn faster with more reliability. You can stop that trial and then put your energy into other things.

And then the Collaborative Innovation Network is when three or more CTSA hubs act collaboratively to develop something innovative which will improve the efficiency of trials.

mPower is a great example – what other strengths do we already possess here that could apply to the RFA?

Well what you said is important, because we want to be prepared to respond for this without chasing after something we’re not good at, or that we don’t have strong interest in, or that doesn’t tie in with our strategic aims.

But we already have an emphasis in technology and methodology as demonstrated by our clinical trial methodology pillar. We didn’t know they were going to have RICs and TICs, but we have a pre-existing emphasis on that, so that’s a big advantage.

On community engagement, which fits into the RIC side, we are ahead of the game because of the Center for Community Health and our Community Advisory Group and the efforts we’ve put in to community engagement. And structurally, we’re in a great place to look at what’s happening in the community, because we have a relatively simple and contained health care system, with two major providers, and one regional health database. Most communities aren’t that centralized.

We recently joined a large network called NIPTE where producing drugs or interventional agents can be done from basic synthesis all the way out to packaging and delivering. So that’s an additional strength.

Phil Ng and Adam Tatro have developed a tool that uses i2b2 to extract from the EMR and put into a REDcap database. They just presented that recently and it got a lot of attention because most centers don’t have that, so that could be part of an application, because we’re already developing new biomedical informatics tools to help assist in making trials more efficient.

So I think we’re going to be able to tap a few strategic domains, because they resonate well with what we’ve already been doing and what we want to improve on. And there are more that I haven’t mentioned, but that’s what Martin and Nana and I are thinking about right now: Where we are well placed to apply as a center – a RIC or a TIC – or if there’s something we should apply in to be part of an Collaborative Innovation Network.

Previous directors’ updates:

March 2015 – Martin Zand introduces himself and discusses his interest in informatics and population-based research.February 2015 – Nana Bennett discusses the CTSI’s Seminar Series on population health.January 2015 – Harriet Kitzman reflects on her time as a CTSI co-director.December 2014 – Karl Kieburtz offers his takeaways from the CTSI all-hands retreat.November 2014 – Nana Bennett speaks to the expansion of the role of the CTSI’s Community Advisory Council.October 2014 – Harriet Kitzman discusses the science of team science.September 2014 – Karl Kieburtz talks about why the CTSI is beefing up its informatics team.August 2014 – Nana Bennett discusses the new Population Health pillar.July 2014 – Harriet Kitzman offers her takeaways from the Mini Summer Research Institute.June 2014 – Karl Kieburtz gives an overview of the CTSI’s six pillars.